Abbokinase / Urokinase

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Modified on 2009/10/14 21:52 by admin
Abbokinase, also known as urokinase, is derived from cultures of human kidney cells from newborns who have died of natural causes. The drug was originally approved in the United States as a remedy to dissolve blood clots in the lungs and heart arteries. It was also approved to help clear intravenous catheters. Side effects of the medication include, but may not be limited to, fever, low blood pressure and bleeding or oozing from cuts, wounds, the gums, or around the place of injection.

In January 1999, the U.S. Food and Drug Administration (FDA) issued a letter to health care providers in order to alert them to important safety information regarding the use of Abbokinase. The letter included information about the potential risks of the product for transmitting infectious agents. It also recommended that Abbokinase be reserved for only those situations where a physician has considered the other available treatment alternatives and has determined that the use of Abbokinase is critical to the care of a specific patient in a specific situation. In addition, at the FDA's request, Abbott changed the labeling of the product to include additional information to reflect these safety concerns so that physicians would have a clear understanding of the risks of using Abbokinase.

Later that year, during inspections of Abbott Laboratories, Abbokinase's manufacturer, and of BioWittaker, Inc., Abbott's supplier of human kidney cells, the FDA identified numerous significant deviations from Current Good Manufacturing Practice (CGMP) regulations designed to assure product safety. A number of in-process lots of Abbokinase were contaminated with microorganisms, which had the capability of causing respiratory infections and, on rare occasions, other more serious illnesses. As a result, the FDA ordered Abbott to stop distribution of the drug in early 2000 until the pharmaceutical company corrected these problems.

In October 2002, FDA and Abbott announced the reintroduction of Abbokinase for use in the lysis of massive pulmonary emboli and pulmonary emboli accompanied by unstable hemodynamics. The WARNINGS section of the labeling was strengthened to include post-marketing reports of anaphylaxis (hypersensitivity), other infusion reactions, and class information regarding the potential for cholesterol embolization. The ADVERSE REACTIONS section of the product labeling reflects the analysis of post-marketing safety data.

If you have experienced an adverse reaction after being administered Abbokinase, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.



See Also

  1. Blood Thinning Drugs: Overview
  2. Excessive Bleeding: Overview
  3. Low Blood Pressure (hypotension): Overview
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